Identity
- Trade Name
- Aquaflex Ultrasound Gel Pad EUDAMEDAQUAFLEX FDA UDI
- Generic Name
- Electrode conductive medium FDA UDI
- Device Name
- Aquaflex Gel Pad EUDAMEDAquaflex Ultrasound Gel Pad, 2cm x 9cm gel pad FDA UDI
- Model / Reference
- 04-02 EUDAMEDULTRASOUND GEL PAD FDA UDI
- Description
- Aquaflex Ultrasound Gel Pad, 2cm x 9cm gel pad FDA UDI
Identifiers
- Catalog Number
- 04-02 FDA UDI
- Primary DI / UDI-DI
- 20855683006139 EUDAMED10855683006132 FDA UDI
- Basic UDI-DI
- 085568300604000H8 EUDAMED
- Unit of Use DI
- 00855683006135 EUDAMED
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electrode conductive medium FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aquaflex Ultrasound Gel Pad by Parker Laboratories, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085568300604000H8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
- EUDAMED SRN
- US-MF-000013857
- Authorised Representative
- Parker Laboratories, BV NL-AR-000012618
Sources (2)
- EUDAMED 91c949e0-2931-4fe9-95c5-715ff7957195 61 fields · synced Oct 6, 2026
- FDA UDI 0d75ec2f-77a2-4ab5-9b21-d0d79d7133d8 35 fields · synced May 30, 2026